Dr. Reddy's receives USFDA approval for Ranitidine (Zantac) Tablets, 150mg (OTC) - First major approval for its U.S. OTC business
September 19, 2007 (PRLEAP.COM) Health NewsDr. Reddy’s Laboratories (NYSE:RDY) announced today, that the U.S. Food and Drug Administration (USFDA) has granted final approval for the Company’s Abbreviated New Drug Application (ANDA) for Ranitidine (Zantac™) 150mg tablet (Over-the-Counter). The Company is the only generic manufacturer to receive FDA approval for this product following the expiry of innovator’s patents. This is the first approval for Dr. Reddy’s U.S. OTC business unit following an announcement in mid-May, to launch a Store Brand OTC Division in the U.S.
Commenting on the approval, Mark Hartman, President, North America Generics said,
“We are excited about the Ranitidine 150mg approval as it will complement our Ranitidine 75mg OTC entry. This approval will help establish Dr. Reddy’s in the U.S. OTC business segment. The company has plans to expand its OTC product portfolio and additional introductions are planned in the coming months that will certainly include Rx switches and select OTC Monograph products”.
The company will distribute the 150mg strength in blister counts of 8 and 24’s as well as bottles of 50, 65 and 95 counts.
About Dr. Reddy’s:
Established in 1984, Dr. Reddy's Laboratories (NYSE: RDY) is an emerging global pharmaceutical company with proven research capabilities. The Company is vertically integrated with a presence across the pharmaceutical value chain. It produces finished dosage forms, active pharmaceutical ingredients and biotechnology products and markets them globally, with focus on India, US, Europe and Russia. The Company conducts research in the areas of diabetes, cardiovascular and cancer. www.drreddys.com